Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Status: Completed
Location: See all (44) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• History of recurrent symptomatic paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following:

⁃ a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes within six months prior to enrollment, and one electrocardiographically documented AF episode within 12 months prior to enrollment.

• No amiodarone use within 90 days prior to enrollment;

• Subjects who are indicated for an ablation procedure for paroxysmal atrial fibrillation (PAF) according to 2017 HRS expert consensus statement on catheter and surgical ablation of atrial fibrillation;

• Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication;

• Subjects who are willing and capable of providing informed consent;

• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;

• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Locations
United States
Arkansas
Arrhythmia Research Group
Jonesboro
Arizona
Banner University Medical Center
Phoenix
Pima Heart and Vascular
Tucson
California
Cedars - Sinai Medical Center
Los Angeles
Mercy General Hospital
Sacramento
Torrance Memorial Medical Center
Torrance
Florida
Tallahassee Memorial Hospital
Tallahassee
AdventHealth Tampa
Tampa
St. Joseph's Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Illinois
Rush University Medical Center
Chicago
Massachusetts
Southcoast Physicians Group
Fall River
Missouri
St. Luke's Hospital of Kansas City
Kansas City
New Jersey
Valley Hospital
Ridgewood
New York
Mount Sinai Medical Center
New York
Northwell Health
Staten Island
St. Joseph's Hospital Health Center
Syracuse
Ohio
Cleveland Clinic Foundation
Cleveland
Kettering Medical Center
Kettering
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
York Hospital
York
Tennessee
Stern Cardiovascular Foundation, Inc.
Germantown
Vanderbilt University Medical Center
Nashville
Texas
Baylor Heart & Vascular Hospital
Dallas
Christus Trinity Mother Frances Health System
Tyler
Virginia
Chippenham & Johnston-Willis Hospital
Richmond
Virginia Commonwealth University Health System
Richmond
Washington
PeaceHealth Southwest Medical
Vancouver
Wisconsin
Aurora Health Care
Grafton
West Virginia
St. Mary's Medical Center
Huntington
Other Locations
Belgium
UZ Brussels
Brussels
Canada
Hamilton General Hospital
Hamilton
Institut de Cardiologie de Montreal
Montreal
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Quebec
Vancouver General Hospital
Vancouver
France
CHU Grenoble - Hopital Michallon
Grenoble
Germany
Herz-und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen
Universitaetsklinikum Schleswig-Holstein
Lübeck
Hong Kong Special Administrative Region
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital
Sha Tin
Italy
Maria Cecilia Hospital SPA
Cotignola
Netherlands
Erasmus MC- University Medical Center Rotterdam
Rotterdam
Taiwan
Taipei Veterans General Hospital
Taipei
National Taiwan University Hospital
Taipei City
Time Frame
Start Date: 2020-06-24
Completion Date: 2023-08-17
Participants
Target number of participants: 458
Treatments
Experimental: Cryoablation
Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov